Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
This is a series of notes on clinical pathology, useful for postgraduate students and practising pathologists. It covers all internal and external quality control techniques. The topics are presented point wise for easy reproduction.
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
Randox Quality Control's next 'Improving Laboratory Performance Through Quality Control' educational guide has been published with helpful tips that your laboratory can use in order to ensure it has effective troubleshooting procedures in place.
So you ran QC this morning and realised that one of your analytes has been flagged as 'out-of-control', what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it's within range or do you halt patient testing and investigate the source of the error?
When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it's important that you have standard operating procedures in place, outlining what to do in the event of an out-of control error. Errors occur in laboratories all over the world. A lab with effective troubleshooting procedures in place will still have errors but will be able to detect them, quickly reducing their impact and reducing the risk of wasting both time and money.
How often is Right for Laboratory Quality Control?Randox
Improving Laboratory Performance Through QC - How often is right for QC? Ask the Right Questions to get the Right Answers.
It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Is running QC once per day really sufficient? what is the "right" frequency for running QC samples in your laboratory?
This is a series of notes on clinical pathology, useful for postgraduate students and practising pathologists. It covers all internal and external quality control techniques. The topics are presented point wise for easy reproduction.
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
Randox Quality Control's next 'Improving Laboratory Performance Through Quality Control' educational guide has been published with helpful tips that your laboratory can use in order to ensure it has effective troubleshooting procedures in place.
So you ran QC this morning and realised that one of your analytes has been flagged as 'out-of-control', what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it's within range or do you halt patient testing and investigate the source of the error?
When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it's important that you have standard operating procedures in place, outlining what to do in the event of an out-of control error. Errors occur in laboratories all over the world. A lab with effective troubleshooting procedures in place will still have errors but will be able to detect them, quickly reducing their impact and reducing the risk of wasting both time and money.
How often is Right for Laboratory Quality Control?Randox
Improving Laboratory Performance Through QC - How often is right for QC? Ask the Right Questions to get the Right Answers.
It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Is running QC once per day really sufficient? what is the "right" frequency for running QC samples in your laboratory?
Improving Laboratory Performance Through Quality Control - The role of EQA in...Randox
Randox Quality Control's five simple steps to QC success. The second education guide from Randox QC for clinical laboratory staff. The guide will examine how EQA works, benefits of EQA and what a laboratory should look for when choosing an EQA scheme.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
Validation of lab instruments and quantitative test methods Mostafa Mahmoud
This lecture shows the procedures applied when going to validate your laboratory instruments and quantitative test methods also either FDA approved or laboratory developed tests.
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The webinar covers:
• Introduction to QA in Laboratories
• Internal Quality Control Techniques
• External Quality Control Techniques
Presenter:
This webinar was presented by Hamidreza Dehnad, PECB Certified Trainer and CEO of Pasargad Quality Pioneers (PQP).
Link of the recorded session published on YouTube: https://youtu.be/IbWcJQDULYA
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Randox
Randox Quality Control's latest educational guide examines Internal Quality Control, External Quality Assessment, Why laboratories should run QC, How often laboratories should run QC, Basic QC statistics and the quality control process.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in the production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
This presentation gives a brief idea of Quality control and how to execute it.
Improving Laboratory Performance Through Quality Control - The role of EQA in...Randox
Randox Quality Control's five simple steps to QC success. The second education guide from Randox QC for clinical laboratory staff. The guide will examine how EQA works, benefits of EQA and what a laboratory should look for when choosing an EQA scheme.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
Validation of lab instruments and quantitative test methods Mostafa Mahmoud
This lecture shows the procedures applied when going to validate your laboratory instruments and quantitative test methods also either FDA approved or laboratory developed tests.
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The webinar covers:
• Introduction to QA in Laboratories
• Internal Quality Control Techniques
• External Quality Control Techniques
Presenter:
This webinar was presented by Hamidreza Dehnad, PECB Certified Trainer and CEO of Pasargad Quality Pioneers (PQP).
Link of the recorded session published on YouTube: https://youtu.be/IbWcJQDULYA
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Randox
Randox Quality Control's latest educational guide examines Internal Quality Control, External Quality Assessment, Why laboratories should run QC, How often laboratories should run QC, Basic QC statistics and the quality control process.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in the production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
This presentation gives a brief idea of Quality control and how to execute it.
Monitoring External Quality Assessment / Proficiency Testing Performance - Investigating the source of the problem.
In order to identify the source of the problem it is useful to be aware of the most common causes of poor EQA performance. Errors can occur at any
stage of the testing process however EQA is most concerned with detecting analytical errors i.e. errors that occur during the analysis of the sample.
Most analytical errors can be easily divided into three main areas; clerical errors, systematic errors and random errors. Systematic errors result in
inaccurate results that consistently show a positive or negative bias. Random errors on the other hand affect precision and result in fluctuations in
either direction.
RIQAS External Quality Assessment for Medical Laboratories Randox
RIQAS (Randox International Quality Assessment Scheme) is the world's largest global EQA provider serving over 24,000 laboratory participants in more than 105 countries. Our comprehensive programme offering covers a wide range of routine and esoteric analytes enabling laboratories to significantly reduce the number of programmes they participate in while helping to reduce costs at the same time.
More than 24,000 laboratory participants
Present in over 105 countries
22 flexible EQA programmes
Cost effective options to suit all labs
Accredited to ISO/IEC17043:2010
Frequent analysis with rapid feedback
User friendly yet comprehesive reports
End-of-cycle reports provided
Submit results and view reports online via RIQAS.net
Register up to five analysers per programme at no extra cost
There are different types of QC material and each format will have it's own advantages & disadvantages. Each format will also need to be handled differently and this guide aims to explain the different methods for preparing each type of control.
The laboratory shall determine measurement uncertainty for each measurement procedure,
in the examination phases used to report measured quantity values on patients’ samples. The
laboratory shall define the performance requirements for the measurement uncertainty of each
measurement procedure and regularly review estimates of measurement uncertainty.
Acusera 24.7 Interlaboratory Data Management Randox
Acusera 24•7 Live Online is an interlaboratory data management package designed to complement the Acusera range of Internal Quality Controls. Created to help laboratories effectively manage and interpret their QC results, the analytical capabilities of Acusera 24•7 Live Online, coupled with the superior quality and flexibility of our Acusera control range, will revolutionise your laboratory's workflow enabling early identification of any trends or system errors.
Acusera 24.7 Live Online will automatically calculate internal QC statistics including mean, standard deviation and CV. The ability to apply user defined QC multi-rules will help to reduce false rejections and maintain a high level of error detection.
Online access anytime, anywhere
Peer group data from over 20,000 participants
Peer group statistics updated daily
Unique dashboard highlights poor performance
Interactive charts combining multiple analytes, lots and instruments
Comprehensive reports including audit trail reports to aid accreditation
Automated QC result entry via Acusera 24•7 Connect
Multi-reglas de control de calidad (CC) son diseñadas y utilizadas para minimizar falsos rechazos y mantener una alta tasa de detección de errores. Hay seis reglas principales que son utilizadas para determinar si los resultados de una serie de muestras de pacientes deben ser aceptadas o rechazadas, basadas en el rendimiento de los materiales de control contra los criterios de las reglas. Diferentes combinaciones pueden ser aplicadas en función del número de controles, al error total permisible y al instrumento en uso. El siguiente diagrama de flujo se usa a menudo para determinar si una corrida debe ser aceptada o rechazada.
Acusera Third Party Quality Controls for Medical Laboratories Randox
With over 350 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover the availability of truly independent third party controls coupled with the added advantages of highly accurate target values, increased stability and unparalleled quality will optimise performance, save valuable time and minimise waste in any laboratory.
Our comprehensive range of multi-analyte controls have been uniquely developed with ease of use in mind, combining up to 100 parameters in one convenient control laboratories can significantly reduce the need for multiple, costly single analyte controls.
Consolidation
100% human controls for immunoassay purposes
Most accurate target values
Unrivalled stability
Most consistent controls
True third party controls
Master Quality control for clinical laboratories.pptxJULIUSMATERN
https://clinicallabgurus.com/
The secrets to achieving precision and accuracy in clinical laboratories with our groundbreaking eBook, "Mastering Quality Control for Clinical Laboratories." This comprehensive guide empowers laboratory professionals, technicians, and students with the knowledge and skills necessary to ensure the highest standards of quality in diagnostic testing.
Dive deep into the core concepts of quality control, as this eBook takes you on a journey through the laboratory path of workflow. Learn the essential definitions of key terms, including Accuracy, Quality Control Products, Normal Control, Abnormal Control, QC Database, and Validation. Understand the negative consequences of neglecting quality control practices and discover the vital role that quality control products/materials play in maintaining excellence.
Explore the nuanced world of controls, distinguishing between built-in and traditional controls. Gain insights into Electronic Control, Embedded Control, and Traditional Control, and differentiate between Dependent and Independent Quality Control. Delve into the intricacies of open-vial stability versus shelf-life stability and grasp the distinctions between Assayed, Un-assayed, and In-House Control.
Navigate the selection process for quality control materials based on shelf life, open-vial stability, and clinically relevant decision levels. Develop the skills to define and calculate mean, standard deviation, coefficient of variation, coefficient of variation ratio, and standard deviation index, ensuring a robust statistical foundation.
Our eBook doesn't stop there. Learn to identify trends and shifts, construct Levey-Jennings charts, and evaluate graphed data for out-of-control events. Assess instruments, reagents, and control products using the coefficient of variation, and discover how to design quality control when faced with new control and no previous data.
Address common challenges, such as setting ranges without historical data, utilizing temporary SD with limited data, and the effects of relying on package insert data without developing your own mean and SD from your data. Navigate discrepancies in ranges and learn strategic solutions to ensure accuracy and reliability in your laboratory practices.
"Mastering Quality Control for Clinical Laboratories" is your indispensable guide to elevating the standards of clinical laboratory practices. Whether you're a seasoned professional or a student entering the field, this eBook is your key to mastering the art and science of quality control in clinical laboratories. Invest in your expertise, and unlock a new level of precision in diagnostic testing. Order your copy today!
PLEASE JOIN OUR BLOG FOR MORE UPDATES,PRESENTATIONS AND ONLINE COURSES FOR CLINICAL LABORATORY
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control course online certification at
https://www.udemy.com/course/iso-15189quality-control-for-clinical
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Laboratory Total Quality Management, Concept of Laboratory errors, the quality control material, quality assurance program, factors affecting the quality of report, Steps in quality management, PDCA cycle, accuracy, precision, EQAS, IQAS, Proficiency testing.
the details are related to medical laboratory and help MBBS, MD, BSc MLT, MSc MLT, etc
Effective handling of OOS investigations involves adhering to OOS investigation guidelines to ensure thorough analysis and resolution. Following robust protocols and regulatory standards in OOS investigation processes is crucial for maintaining product quality and compliance.
Read more here https://www.ipa-india.org/wp-content/uploads/2023/05/Presentation-on-Handling-OOS-Investigations-Regulatory-Expectations-Dipesh-Shah-Comsumer-Safety-Officer-USFDA.pdf
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
Randox QC offer an extensive range of third party quality controls. Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.
Acusera 24.7 is an interboratory data management software capable of automatically calculating measurement of uncertainty and six-sigma. With real time peer group updates and user friendly comprehensive charts and reports including Levey Jennings and histograms, our Acusera 24.7 software is now smarter, faster and more efficient than ever before!
Acusera 24.7 Interlaboratory Data Management - June 17 LT244Randox
Acusera 24.7 Live Online version 2.0 is here! Faster, smarter and more efficient than ever before, this interlaboratory data management program will be sure to help streamline internal QC in all laboratories regardless of size.
Acusera Verify Linearity Verification - June 17 LT674Randox
Our Acusera Linearity Sets are perfect for laboratories wishing to challenge the full reportable range of their instruments. With sets available for Roche & Beckman analysers, our sets are sure to meet all your laboratory and regulatory requirements.
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries.
White Paper Quality Control for Point of Care TestingRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient.
QC Multi-rules are designed and used to minimise false rejections and maintain a high rate of error detection. There are six main rules used to determine if results from a run of patient samples should be accepted or rejected, based on the performance of control materials against the rule criteria. Different combinations can be applied depending on the number of controls in use, total allowable error and the instrument in use. The flow chart below is often used to determine if a run should be accepted or rejected.
QC Multi rules - Improving Laboratory Performance Through Quality ControlRandox
Randox Quality Control's latest educational guide examines and explains what QC Multi-Rules are, How to identify an out of control event with QC rules, How to use QC Multi-Rules, The different types of analytical errors, The tools to assist labs and how a lab can troubleshoot QC errors.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
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Designing an appropriate QC procedure for your laboratory
1. Q
QUALITY CONTROL
Designing an Appropriate QC Procedure for Your Laboratory
Complete QC solutions for results you can trust
Improving Laboratory Performance Through Quality Control
Five simple steps for QC success
2. 2
1
5
The Importance of a well-designed QC Procedure
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient.We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
An effective QC strategy is not as complicated as you might think, it does not
require you to become an ‘advanced mathematician’. If you stick to these five simple
steps you can be assured that you are releasing quality QC results.
2
5 Simple Steps
for QC Success
3
Identify the Quality
Specifications for the test
Choose Good Quality
Control Materials
4
Start and End
Patient testing with
a QC evaluation
Ensure you know
the characteristics
of good QC results
Ensure you are
able to recognise
and troubleshoot
an out-of-control
event
3. 3
1. Identify the Quality Specifications for the test
• Not every test performs the same
• Not every test needs to perform the same
• Give poor-performers and high risk tests more QC attention
Not every test in the laboratory performs the same way. Some tests for example are the well-known, well liked, laboratory “good-
performers, always showing excellent recovery rates. However, other tests such as the laboratory “poor-performers”, show a lot
more inconsistencies in performance, and can often be slightly more problematic and frustrating.
You can identify which tests generally perform better, through monitoring your precision over time, via method validation and
comparing your performance to peers through either an EQA scheme or through a peer-group reporting software. Using this
differentiation, afford your“poor-performer” QC tests, a little more QC attention. Run QC more frequently and monitor the results
closely, to ensure that they are both accurate and reliable.
It is also important to remember that not every test needs to perform the same. Some tests, compared to others, have a little more
scope for error before they have an impact on patient care. It is therefore important to ensure that you identify the important
“high risk tests”. Any tests that have one or more of the following characteristics, should be considered high risk:
• A test where there could be a detrimental consequence, should the wrong result be released
• A test that supports the clinicians decision in isolation
• A test that is acted upon immediately
• A test that is performed on a specimen that is difficult/painful to collect
Additionally, make sure you take note of the CLIA analytical quality requirements, to identify the quality specifications of particular
tests. For any test that you identify as high risk, make sure you run QC more frequently and play close attention to your QC results.
“It’s important that you know which tests are your well performing tests
and which are your poor performing tests.”
4. 4
2. Choose Good Quality Control Materials
The effectiveness of any QC procedure is underpinned by the quality of the control materials that you choose to use. ISO 15189
recommends that the
It is important to note that differently manufactured QC material, will not perform in the same way. It is of utmost importance that
you choose the best quality material available on the market, as you may otherwise be putting patients at risk.
Look out for the following qualities in your QC material:
• Have accurately assigned values; the narrower the control ranges used, the more efficient you will be at assessing your
performance. Unfortunately, many manufacturers assign their QC values based on only a handful of results, meaning that control
ranges are far too wide to monitor performance effectively. Choose materials that have assigned values based on thousands of
laboratory results.
• QC material that is “as close as possible to a patient samples”; as recommended by ISO 15189; In order to behave
and react like a patient sample, the material needs to be in a matrix similar to a patient’s as this will allow the best assessment of
performance. Look out for materials that are described as 100% or fully human and look out for lyophilised products that are free
from any artificial materials and preservatives. Many manufacturers describe their material as “human-based”, as these materials
contain components of animal origin and will not be “as close to a patient sample” as possible. This is particularly important
for anti-body based tests. Make sure you check your QC kit insert to ensure you are using 100% human material and that your
lyophilised material is free from preservatives.
• A format suitable for use; QC materials come in lyophilised, liquid-frozen and liquid ready-to-use formats. Lyophilised materials
are great for hotter climates. Liquid frozen and liquid ready-to-use samples, eliminate the chance of reconstitution errors, with
liquid ready-to-use samples requiring the least effort for preparation, saving you time and making them
ideal for point of care testing.
• Are they third party materials; ISO 15189 recommends the “use of
independent third party control materials”.Third party materials offer many
advantages, enabling an unbiased assessment of performance that can be
used on all instrument platforms.
• Cover the full clinical range; ISO 15189 recommends that the
“laboratory should choose concentrations of control materials,
wherever possible, especially at or near clinical decision values,
which ensure the validity of the decisions made”.
• Match their stability claims; Many manufacturers, in an
attempt to make their material ‘look better’, give inaccurate
stability claims and often give different stability claims for different
analytes in the material. Don’t forget that a QC material is only as
stable as its least stable analyte. Make sure your QC manufacturer
is being honest about their stability claims and avoid those who
make different stability claims for different analytes in the same
sample.
“laboratory shall use quality control materials that react to the
examining system in a manner as close as possible to patient samples”.
5. 5
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
+3
+2
+1
M
-1s
-2s
-3s
+3
+2
+1
M
-1s
-2s
-3s
68.26%
95.46%
99.73%
3. Start and End Patient testing with a QC evaluation
Make sure you are testing patient samples in “batches” and are starting and ending patient sampling with a QC evaluation. If you
only run QC every morning and one morning you find that your QC is out of range, you may be unaware as to whether the
malfunction occurred the previous day or not.Your staff will have to troubleshoot, without knowing if the previous days results have
been affected or not, by re-running samples, perhaps unnecessarily.
Running QC at the end of the day, assures you that that day’s results are not affected, saving you a lot of time and money! If your
lab runs in 24hr operation, make the time between QC evaluations shorter than the time needed to correct erroneous results, as
this is the most cost effective strategy for your lab. Additionally, ensure that you know the number of patient results between QC
evaluations, as this will help you ascertain the number of patients at risk, should an out-of control event occur.
4. Ensure you know the characteristics of good QC results
In order to recognise a “bad” result, it is important that you are able to recognise the qualities of a “good” set of QC results. In an
ideal world, the characteristics of good/normal QC results on a Levey-Jennings chart should;
• Fluctuate randomly around the mean for comparison. There should be an equal number of results above the mean
as below the mean.
• Very rarely exceed 3SD; 3 in every 1000 results should be outside 3SD
• On the whole be within 1SD.
• On Occasion exceed 2SD; It is normal for 1/20 results to exceed 2SD
It is important to keep these normal characteristics in mind when examining your QC results, to ensure you are not falsely rejecting
acceptable results. Ensure you are maintaining a record of your QC results, to evaluate over time, the norm for your laboratory.
There are various QC management software packages available on the market, that make monitoring your QC results easy. Some
QC management software packages also have functionality that allows you to compare your results to other laboratories, using the
same system as yourself. Knowing that you are comparing well to others, provides you with confidence that your results are in fact
good/normal. Look out for software that allows:
• Multiple instrument registrations
• Results to be entered online, anywhere, any time.
• Real time monitoring of peer group data. Ideally peer group data should be updated daily.
• Interactive charts such as Levey-Jennings and Histogram charts
• Different user level accounts so that lab managers can keep trace of the entering and acceptance of results.
• User defined multi-rules, to be applied to QC results, so that results can automatically be rejected or accepted.
6. 6
5. Ensure you are able to recognise and troubleshoot an out-of-control event
• The most effective way to recognise errors is to use QC multi-rules
• Participate in a ISO 17043 accredited EQA scheme to help recognise errors
• Make sure you estimate the magnitude and size of the out of control event, before you correct it
There are various approaches for recognising possible out-of-control events. Some labs use a single rule and other labs opt to use
QC multi-rules. It is important for whatever rule(s) you use, that you are able to identify errors quickly and effectively, without
falsely rejected results, wasting time and money. It is also important that you choose assayed QC material that has tight ranges or
conversely assign the ranges yourself to ensure you have effective error detection.
Recognising out-of-control QC results using a Single rule
A laboratory favourite is the 1 result outside 2SD rule.This is a great rule for alarming possible out-of-control events, however, you
must be careful as it does have a high false rejection rate. Remember, it is normal for 1/20 results to be outside 2SD! It is important
that you also consider the strategy you use when you have a result outside 2SD. Avoid the “repeat, repeat, repeat… got lucky!”
tactic.This is not an effective error detection method, as if 2/3 results exceed 2SD you may have a problem at hand that is worth
investigating further. In short, be careful when using 1 result outside 2SD rule and ensure that if you do repeat, you do so only
once!
Another single rule that is sometimes used, is when 1 result is outside 3SD.This rule has a very low false rejection rate. Remember
only 3 in 1000 results should be outside 3SD. However, this is not the best rule for sensitive error detection. This rule ideally
shouldn’t be used in isolation.
Recognising out-of-control QC results using Multi-rules
Using a combination of multi-rules is the most effective way of recognising out-of-control events. Applying multi-rules means that
you will have a high rate of error detection, whilst maintaining a low rate of false rejection.This means you will run less unnecessary
repeats and waste less time carrying out unnecessary troubleshooting, in turn saving you money.
As a general rule, apply more multi-rules to poor-performer tests and high risk tests.With stable, good-performer, you can use less
multi-rules.The diagram below summarises a variety of commonly used multi-rules.
Control
Data
1
2S
1
3S
2
2S
R
2s
4
1S
10
X
No
Yes
IN - CONTROL ACCEPT RUN
OUT - OF - CONTROL REJECT RUN
No No No No
Yes Yes Yes Yes Yes
7. 7
Conclusion
Armed with these 5 simple steps, you can be assured that you are on the way to producing
an effective and simple QC strategy, reducing the risk of harm to your patients. Remember
that you do not need to become a statistician to design effective QC procedures.
Improvement in your QC procedures simply requires the desire and determination to
take incremental steps. With each step you take, the next step becomes easier and you
will soon reach your goal of QC success!
When an out-of-control event has occurred, ISO 15189 requires laboratories to
“evaluate the results from patient samples that were examined
after the last QC event”.
Participate in an Accredited EQA Scheme
QC alone isn’t sufficient for detecting errors and so you should participate in an IS0 17043 accredited EQA scheme. ISO 15189
states that the “laboratory should participate in interlaboratory comparison programmes”. Not only will EQA help you detect
errors, it will provide you, the physicians and patients you supply results to, confidence and evidence that you are releasing accurate
patient results.
Troubleshooting Out-of-Control Events
Make sure you estimate the magnitude and size of the out of control event before you correct it. It’s a good idea to take note and
monitor your average patient mean or test a known patient sample.That way, you can measure the extent of the problem and the
effect the out-of-control event has had on patient results. Measuring the direction and magnitude of the shift in results, can help you
decide whether any clinical significant errors may have occurred and whether or not you need to repeat the patient results.
Ensure you know how many samples were run from the last QC event and do not release any patient results until the problem has
been rectified.
8. 8
Information correct at time of print. Randox Laboratories Limited is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered
Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic
procedures in the USA.
QUALITY CONTROL
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com
find out more
24•7
Compatible for use with the Acusera range of third party controls, the Acusera
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MAR15